Evidence Snapshot
Regulatory Context
Emideltide, commonly called delta sleep-inducing peptide (DSIP), is not a component of an FDA-approved drug and has no FDA-approved indication for insomnia, narcolepsy, opioid withdrawal, or any other use. FDA's 2026 scientific evaluation found the evidence preliminary, inconsistent, and inadequate to establish effectiveness for chronic insomnia, narcolepsy, or opioid withdrawal, and identified inadequate characterization and unresolved immunogenicity, aggregation, and impurity concerns. On July 24, 2026, the Pharmacy Compounding Advisory Committee reportedly voted against recommending emideltide for 503A-list inclusion (seven against, six in favor, one abstention); the vote was advisory and nonbinding, but no FDA approval, approved indication, or approved dosing regimen exists.
In Plain English
A quick, research-focused overview. It does not replace, and cannot outrank, the detailed evidence below.
What is it?
Delta sleep-inducing peptide (DSIP) is a nonapeptide investigated in small human sleep studies during the 1980s and early 1990s. Results were mixed, and modern confirmatory development is lacking.
Why are researchers interested in it?
DSIP was proposed to influence sleep regulation and other stress-related physiology, but a specific validated receptor and a reproducible endogenous sleep-control role have not been established.
What does the evidence look like?
Evidence grade C/D. Human, preclinical, regulatory, and review evidence must remain separated.
Biggest things to know
Human studies were small, old, and methodologically heterogeneous.
Research Takeaway
Delta sleep-inducing peptide (DSIP), also referred to by FDA as emideltide, is a nonapeptide; emideltide free base and emideltide acetate are distinct bulk drug substances and should not be treated as automatically interchangeable formulations.
Evidence boundary: The name DSIP does not validate the identity, salt form, purity, or concentration of a commercial product.
See all 6 evidence claims →Quick Summary
Emideltide, commonly called delta sleep-inducing peptide or DSIP, is a synthetic nonapeptide investigated in small human sleep studies during the 1980s and early 1990s. Results were mixed, and modern confirmatory development is lacking. FDA's 2026 evaluation found the evidence preliminary and inadequate to establish effectiveness for chronic insomnia, narcolepsy, or opioid withdrawal, and a July 2026 advisory committee voted against recommending emideltide for possible 503A compounding-list inclusion.
Mechanism & Research Overview
DSIP was proposed to influence sleep regulation and other stress-related physiology, but a specific validated receptor and a reproducible endogenous sleep-control role have not been established.
Evidence Claims
Individual scientific statements drawn from the sources cited below, each shown with the specific evidence boundary that statement does not establish.
Supported
Delta sleep-inducing peptide (DSIP), also referred to by FDA as emideltide, is a nonapeptide; emideltide free base and emideltide acetate are distinct bulk drug substances and should not be treated as automatically interchangeable formulations.
Does not establish
Evidence boundary: The name DSIP does not validate the identity, salt form, purity, or concentration of a commercial product.
Sources: FDA Evaluation of Emideltide-Related Bulk Drug Substances
Supported
Small historical human sleep studies report a mixed picture: at least one placebo-controlled crossover study (Monti et al. 1987) found no significant sleep-outcome advantage over placebo, while other small studies reported limited or inconsistent improvements. The evidence base is old, limited in sample size, and not supported by a modern pivotal insomnia-development program.
Does not establish
Evidence boundary: Historical sleep-laboratory signals do not establish current standard-of-care efficacy for chronic insomnia.
Sources: Effects of delta sleep-inducing peptide on sleep of chronic insomniac patients; Efficacy of DSIP to normalize sleep in middle-aged and elderly chronic insomniacs; Study of delta sleep-inducing peptide efficacy in improving disturbed sleep in chronic insomniac patients
Supported
DSIP/emideltide is not an FDA-approved drug; FDA's 2026 review weighed against 503A Bulks List inclusion, and July 2026 advisory consideration did not create an approved drug status.
Does not establish
Evidence boundary: Compounding-list review and advisory votes are separate from FDA approval of safety and effectiveness.
Sources: FDA Evaluation of Emideltide-Related Bulk Drug Substances; July 23-24, 2026 Pharmacy Compounding Advisory Committee — Meeting Materials
Supported
FDA states that it lacks sufficient safety information for compounded emideltide/DSIP and identifies peptide-characterization and immunogenicity concerns for proposed routes of administration.
Does not establish
Evidence boundary: Lack of adequate safety data is not proof of harm but must not be represented as evidence of safety.
Sources: Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks; FDA Evaluation of Emideltide-Related Bulk Drug Substances
Supported
The frozen evidence does not establish DSIP as a proven treatment for chronic insomnia, narcolepsy, opioid withdrawal, anxiety, or generalized sleep optimization.
Does not establish
Evidence boundary: Use nominations and small historical studies do not establish approved indications.
Sources: Effects of delta sleep-inducing peptide on sleep of chronic insomniac patients; FDA Evaluation of Emideltide-Related Bulk Drug Substances; July 23-24, 2026 Pharmacy Compounding Advisory Committee — Meeting Materials
Supported
Grey-market or compounded DSIP products are unapproved and cannot be presumed equivalent to historical research material; only named-study dosing may appear as Study/Trial Dosing, with no consumer sleep, withdrawal, reconstitution, or injection protocol.
Does not establish
Evidence boundary: This does not endorse use of DSIP or provide individualized treatment guidance.
Sources: FDA Evaluation of Emideltide-Related Bulk Drug Substances; July 23-24, 2026 Pharmacy Compounding Advisory Committee — Meeting Materials
Safety & Evidence Limitations
Considerations reported in the sources cited on this page — not a complete list of every possible risk, and not medical advice.
Safety Consideration
Human studies were small, old, and methodologically heterogeneous.Safety Consideration
The study concluded that any DSIP-related sleep improvement was of little clinical significance, and that apparent stage-specific differences reflected pre-existing baseline imbalance rather than a true treatment effect.Safety Consideration
Pharmacokinetics, product identity, long-term safety, and a validated receptor mechanism remain uncertain.
Research Areas Being Studied
Research areas discussed on this page reflect the Sleep / Circadian category and the sources cited below.
Findings Reported in Studies
Educational summary only — reported in cited studies, not a claim of proven benefit.
- Effects of delta sleep-inducing peptide on sleep of chronic insomniac patients (1992):
- Study of delta sleep-inducing peptide efficacy in improving disturbed sleep in chronic insomniac patients (1987):
- Efficacy of DSIP to normalize sleep in middle-aged and elderly chronic insomniacs (1986):
- DSIP and insomnia report ():
Study Tables by Evidence Type
Human Studies & Clinical Data
| Title | Year | Population / Model | Dose / Duration / Finding | Safety Notes | Source |
|---|---|---|---|---|---|
| Effects of delta sleep-inducing peptide on sleep of chronic insomniac patients | 1992 | 16 chronic insomnia patients | A small double-blind matched-pairs study reported limited changes in sleep measures, with results not sufficient for firm clinical conclusions. | Small sample, older methods, and limited replication. | |
| Study of delta sleep-inducing peptide efficacy in improving disturbed sleep in chronic insomniac patients | 1987 | Chronic insomnia patients | A double-blind, placebo-controlled crossover study in chronic insomnia patients found no significant difference between DSIP and placebo on key sleep outcomes beyond pre-existing baseline differences; the authors concluded that any DSIP-related sleep improvement was of little clinical significance. | This negative or equivocal placebo-controlled result is important counterevidence. | |
| Efficacy of DSIP to normalize sleep in middle-aged and elderly chronic insomniacs | 1986 | A small sleep-laboratory study reported improvement of sleep measures after DSIP in chronic psychophysiological insomnia. The limited sample, historical methods, and lack of modern confirmatory development materially restrict conclusions. | |||
| DSIP and insomnia report | An older report on DSIP and insomnia, part of the small, heterogeneous, poorly controlled literature FDA found inadequate to establish effectiveness for chronic insomnia. |
Animal / Cell / Preclinical Data
No Animal / Cell / Preclinical Data Listed Yet
This section will be updated as sources are added.
Regulatory Documents & Official Trial Registries
| Title | Year | Population / Model | Dose / Duration / Finding | Safety Notes | Source |
|---|---|---|---|---|---|
| Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks | 2026 | FDA states that compounded Kisspeptin-10 may pose immunogenicity and peptide-characterization risks and that safety information for proposed routes is absent or limited. The same FDA page separately flags Epitalon and emideltide/DSIP for substantial safety-information gaps in compounded use. | |||
| FDA advisers recommend relaxing U.S. rules on compounding peptides | 2026 | On July 24, 2026, the FDA Pharmacy Compounding Advisory Committee reportedly voted to recommend possible 503A-list inclusion of Semax. The recommendation was advisory and nonbinding and did not make Semax FDA approved, establish an indication, prove safety or effectiveness, or create an approved dosing regimen. | |||
| FDA Evaluation of Emideltide-Related Bulk Drug Substances | 2026 | FDA's 2026 scientific evaluation of emideltide/DSIP considered chronic insomnia, narcolepsy, and opioid withdrawal and concluded the evidence was preliminary, inconsistent, poorly controlled, and inadequate to establish effectiveness. FDA also identified inconsistent naming and nomination of both free-base and acetate forms, inadequate characterization, no subcutaneous safety data, limited human exposure information, and unresolved immunogenicity, aggregation, and impurity concerns. | |||
| July 23-24, 2026 Pharmacy Compounding Advisory Committee — Meeting Materials | 2026 | FDA meeting materials state that emideltide/DSIP free base and acetate are not components of an FDA-approved drug and were evaluated for proposed sleep-disorder and opioid-withdrawal uses. The July 2026 advisory process did not convert DSIP into an FDA-approved drug. |
Anecdotal Reported Patterns — Not Medical Advice
Anecdotal Reported Patterns — Not Medical Advice
Reported dosing patterns are included for educational context only. They are self-reported, unverified, not medical advice, and not instructions for human use. Community-submitted patterns are not yet available in this Phase 1 prototype; this section is a placeholder reserved for moderated, aggregated community data.
Lab Markers to Discuss With a Clinician
Educational topics only — not self-monitoring instructions.
FAQ
Disclaimer
Educational information only. This page summarizes published and official research and does not provide medical advice, a recommendation, or instructions for human use.
Educational use only. This content is provided for informational and research-summary purposes only. It is not medical advice, not a treatment recommendation, not a dosing guide, and not a substitute for care from a licensed medical professional. Nothing here is intended to diagnose, treat, cure, prevent, or mitigate disease. Reported dosing patterns, when shown elsewhere on the site, must be labeled either as Study / Trial Dosing or Anecdotal Reported Patterns — Not Medical Advice. Community reports are self-reported, unverified, and not scientific proof.
Community-reported experiences, once enabled, must be displayed only as moderated, anonymized, or aggregated data. They are anecdotal, self-reported, unverified, and should never be presented as proof of safety, efficacy, or expected results.
Content status: Published. Last updated 2026-07-26.
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